CRYSVITA 30 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BUROSUMAB

Available from:

MEDISON PHARMA LTD

ATC code:

M05BX05

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

BUROSUMAB 30 MG / 1 ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

PIRAMAL HEALTHCARE UK LIMITED

Therapeutic area:

BUROSUMAB

Therapeutic indications:

CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and paediatric patients 6 months of age and olderTumor-induced OsteomalaciaCRYSVITA is indicated for the treatment of FGF23‐related hypophosphatemia in tumor‐induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older.

Authorization date:

2020-05-04

Patient Information leaflet

Crysvita 10 20 30-PIL-ENG-D12-F
Crysvita PIL 0122-V2
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS)
- 1986
This medicine is dispensed with a doctor’s prescription only
CRYSVITA 10 MG
CRYSVITA 20 MG
CRYSVITA 30 MG
SOLUTION FOR SUBCUTANEOUS INJECTION
ACTIVE INGREDIENT:
Each vial contains 1 ml of burosumab 10 mg, 20 mg, or 30 mg solution,
respectively.
INACTIVE INGREDIENTS AND ALLERGENS IN THIS MEDICINE: see section 2
"Important
information about some of this medicine’s ingredients" and section 6
"Additional
Information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This
leaflet contains concise information about this medicine.
If you have any further questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It
may harm them, even if it seems to you that their illness is similar
to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
1.1 CRYSVITA is intended for treating adults, and children 6 months
and older who
have XLH.
XLH (X-linked hypophosphatemia) is a genetic disease. People with this
disease
have high levels of a hormone called fibroblast growth factor 23
(FGF23) which
lowers the amount of phosphate in the blood and may lead to bones that
cannot
grow and harden properly.
1.2 CRYSVITA is indicated for the treatment of tumor induced
osteomalacia (TIO), in
cases when the tumor cannot be located or removed, in adult and
pediatric patients
2 years of age and older.
Patients with TIO have higher levels of a hormone called FGF23
produced by certain
types of tumors. FGF23 lowers the amount of phosphate levels in the
blood. The low
levels of phosphate may lead to softening of the bones, muscle
weakness, tiredness,
bone pain and fractures.
THERAPEUTIC GROUP:
CRYSVITA belongs to a group of medicines intended for treating bone
diseases and
of other medicines that affect bone structure and mineralization
(minerals such as
calcium and phosphate depositing in bone)
Crysvita 10 20 30-PIL-ENG-D1

Summary of Product characteristics

1
PHYSICIAN’S PRESCRIBING INFORMATION
1 NAME OF THE MEDICINAL PRODUCT
CRYSVITA 10 mg
CRYSVITA 20 mg
CRYSVITA 30 mg
Solution for Subcutaneous Injection
1.1 QUALITATIVE AND QUANTITATIVE COMPOSITION
CRYSVITA 10 mg solution for injection Each vial contains 10 mg of
burosumab in 1 ml
solution.
CRYSVITA 20 mg solution for injection Each vial contains 20 mg of
burosumab in 1 ml
solution.
CRYSVITA 30 mg solution for injection Each vial contains 30 mg of
burosumab in 1 ml
solution.
2.
THERAPEUTIC INDICATIONS
2.1 X-LINKED HYPOPHOSPHATEMIA
CRYSVITA is indicated for the treatment of X-linked hypophosphatemia
(XLH) in adult and pediatric
patients
6 months
and older.
2.2 TUMOR-INDUCED OSTEOMALACIA
CRYSVITA is indicated for the treatment of FGF23
‐
related hypophosphatemia in tumor
‐
induced
osteomalacia (TIO) associated with phosphaturic mesenchymal tumors
that cannot be curatively resected or
localized in adult and pediatric patients 2 years of age and older.
3.
DOSAGE AND ADMINISTRATION
3.1 IMPORTANT DOSAGE AND ADMINISTRATION INFORMATION
Discontinue oral phosphate and/or active vitamin D analogs (e.g.
calcitriol, paricalcitol,
doxercalciferol, calcifediol) 1 week prior to initiation of treatment
_[see Contraindications (_5_)]_.
Fasting serum phosphorus concentration should be below the reference
range for age prior to
initiation of treatment _[see Contraindications (_
5
_)]._
2
CRYSVITA is administered by subcutaneous injection and should be
administered by a healthcare
provider.
The maximum volume of CRYSVITA per injection is 1.5 mL. If multiple
injections are required,
administer at different injection sites.
3.2 PEDIATRIC PATIENTS WITH X-LINKED HYPOPHOSPHATEMIA (6 MONTHS TO
LESS THAN 18 YEARS OF AGE)
For patients who weigh less than 10 kg, the recommended starting dose
is 1 mg/kg of body weight,
rounded to the nearest 1 mg, administered every two weeks.
For patients who weigh 10 kg and greater, the recommended starting
dose regimen is 0.8 mg/kg of
body weight, rounded to the nearest 10 mg, administered every two
wee